The U.S. Food and Drug Administration (FDA) has approved the use of a nasal spray as a standalone treatment for major depressive disorder, offering a new option for those struggling with treatment-resistant depression.
Why It Matters
Depression rates have reached record highs across the U.S. A Gallup poll from 2023 shows that 29 percent of adults report having been diagnosed with depression at some point in their lifetime, up 10 percentage points from 2015.
This new treatment could help bring relief for millions of Americans struggling with depression.
What To Know
The nasal spray Spravato, which is made from the drug esketamine, had been approved in 2019 for patients who failed to respond to at least two oral antidepressants. However, it had to be used in conjunction with an oral medication.
The FDA has now expanded its approval to include the standalone use of the nasal spray for adults with treatment-resistant major depressive disorder.
The approval was granted following a study that showed Spravato was effective when compared with a placebo, the manufacturer Johnson & Johnson said in a press release.
The study found that after a month, 22.5 percent of patients taking the treatment showed improvements on the Montgomery-Asberg Depression Rating Scale, compared with 7.6 percent of patients taking the placebo.
Esketamine, which Spravato is derived from, is a molecule related to the anesthetic ketamine.
According to the manufacturer, Spravato works by targeting glutamate, which is the brain's most abundant excitatory neurotransmitter and can reduce symptoms in as little as 24 hours.
Johnson & Johnson said that because there are risks of "serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse," the drug will only be available through a restricted program through certified treatment centers.
What People Are Saying
Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine said in a press release: "Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement."
"SPRAVATO® is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants."
What Happens Next
Following the FDA's expanded approval, healthcare providers will now have the option to prescribe Spravato to patients with major depressive disorder, particularly those who haven't responded to previous doses of traditional antidepressants.
English (US) ·